2-Days In-Person Seminar

Human Error Rate Program: How to Investigate, Predict, prevent, correct & recover Human Error (in the manufacturing floor and GMP)

Ginette M Collazo
Boston,MA
Apr 23 - Apr 24 , 2019

Starting at

$1799


Apr 23 - Apr 24 , 2019
Buy Now

Dr. Ginette Collazo — a 20-year veteran of helping drug, biologic and device firms reduce manufacturing errors by 50 percent or more — will conduct a one-of-a-kind workshop that teaches quality managers and manufacturing excellence professionals how to reduce errors and improve quality metrics.

Dr. Collazo recently worked with a drug manufacturer that had a baseline rate of 4.7 errors per thousand units manufactured. But with effective human error reduction strategies, the error rate was reduced to 1.9. A 60% reduction achieved in just 10 months Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges, it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed.

This course offers practical approaches to address human performance issues in GMP related environments by using a specific methodology to investigate, correct, prevent and avoid re-occurrence of these issues.

Learning Objectives:

We will discuss human error categories, near root causes and root causes for these events. We will discuss latest trends in human error issues in the industry.

Register now and get below documents for FREE:

  • RCDT - Root Cause Determination Tool
  • Interview Guide
  • HE Assessment Template
  • Introduction of Tools Material
  • Additional material

Areas Covered :

  • Background on Human Error Phenomena
  • Importance of Human Error Prevention/reduction
  • Training and human error
  • Facts about human error
  • Human Error as the Root Cause
  • What is Human Error
  • How is Human Error controlled?
    • Types of error
    • Human error rates and measurement
    • Trending and tracking
    • Prediction
    • CAPA effectiveness
  • Common mistakes:
    • Memory failures
    • Overconfidence
    • We believe we are above average
    • Visual Detection, Vigilance Effectiveness

Who Will Benefit:

  • Training managers, personnel
  • coordinators
  • Operations
  • Manufacturing
  • Plant engineering
  • QA/QC
  • Process excellence/ improvement professionals
  • Industrial/process engineers
  • Compliance officers
  • Regulatory/legislative affairs professionals
  • General/corporate counsel
DAY 01(8:30 AM - 4:30 PM)
  • Lecture 1: Understanding the Basics of Human Error in Manufacturing
    • How human errors intersect with manufacturing regulations
    • Examples of applicable FDA requirements and what the FDA expects companies to be complying with
    • A review of other industry standards that apply to drug and device manufacturing
    • What FDA investigators look for during inspections and the most common violations found in Form 483s and Warning Letters
    • Which violations tied to human errors and manufacturing are trending up
    • The various types of human errors commonly found on manufacturing floors
  • Break
  • Lecture 2: Human Error and Human Factors
    • The taxonomy of human error; how and why drug and device companies need to focus on this in their investigation processes
    • Why administrative and management systems factor so prominently into deviations and nonconformance.
    • The role of innovative operational controls and their role in reducing human errors
    • When training is appropriate and when we should stop
    • Learn how common day-to-day communication gaps contribute to human error
    • How supervision can be one of the best human error reduction strategies at your site
    • When is individual performance responsible for human error and when does it become a root cause
    • How to address cognition, attention, and memory failures at your site
  • Lunch
  • Lecture 3: Psychology and Human Error
    • How our biology affects our thinking process and individual performance
    • Understanding the latest on cognitive load and attention, memory, and decision-making errors — how they commonly occur on the manufacturing floor
    • How our senses control how we react — it’s more important that you think
    • Best practices for controlling human factors for optimum people performance
    • How to create an organizational environment that supports human error reduction initiatives — from senior management to floor level staff
    • Why our culture with regards to human error has to change; it’s not an easy process but vitally necessary for drug and device companies
  • Break
  • Lecture 4: Corrective and Preventive Action (CAPA) — FDA’s #1 Manufacturing Compliance Problem
    • How to develop corrective actions that make sense —what’s working and not working
    • Creating preventive actions that truly prevent; how to stop errors that have not yet happened
    • Understanding the human error prediction process and tools
    • Prevention and human error control: proven ways to measure improvement and on-going trend analysis
    • When to use detection mechanisms instead of preventive mechanisms — the pros and cons of each
    • Human error detection and recovery rate — are you really uncovering all the errors within your facilities?
    • Assuring the FDA your CAPA program is effective and you’ve adequately focused on human error
DAY 02(8:30 AM - 4:30 PM)
  • Lecture 5: Human Error Reduction Techniques
    • Discussion of insights from Day 1
    • When is human error a human resources issue?
    • How and when to apply engineering controls to correct and prevent human error deviations
    • What to do when individual performance is the major contributor
    • Human error and documentation: from design, construction, change management and implementation.
    • Additional contributors for human errors will be discussed.
  • Break
  • Lecture 6: Human Error Investigation
    • Human error investigation process defined from beginning to end
    • How to gather data in the human error investigation process
    • How to perform an effective interview
    • Important steps for effective human error investigations
    • How to report issues to make sure management listens
  • Lunch
  • Lecture 7: Root Cause Analysis Tools
    • A brief review of common tools used in determining root cause
    • Hierarchy and use of the root cause determination tool for human error investigations
    • How to perform a cognitive load assessment
    • The interview process and interview techniques for human error root cause analysis.
    • When and how to use the human error prediction tool
    • When to perform a process vs. procedure analysis and why it is so important to do so before establishing procedure revision as a CAPA for human error
  • Break
  • Lecture 8: Metrics and Human Error
    • KPI’s
    • Human error rate
    • 1st time pass rate
    • Overall equipment effectiveness (OEE)
    • Trending
    • Tracking
  • Lecture 9: Review and Key Insights Materials
    • Copies of the presentations
    • Pertinent guidance documents
    • Articles on human error
    • Manual tools
    • Interviewing guide
    • Report example
    • Root Cause Determination Tool
Seminar (Price/Register)
Apr 23 - Apr 24 , 2019 (2 Days) Boston,MA

Single attendee


Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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NY 10036

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Speaker: Ginette M Collazo, Organizational Psychologist, Ginette M Collazo Inc

Ginette Collazo, PH.D, is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. She has also implemented human error reduction programs and technology in many small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.


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